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United States · US · US:72888-123_473ce2a5-25a3-811b-e063-6294a90a0456

Guanfacine

In shortageOrange BookUNIISPLATC C02AC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeC02AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7288812300
    1000 TABLET in 1 BOTTLE (72888-123-00)
  • ndc11
    7288812301
    100 TABLET in 1 BOTTLE (72888-123-01)
  • ndc11
    7288812305
    500 TABLET in 1 BOTTLE (72888-123-05)
  • ndc11
    7288812330
    30 TABLET in 1 BOTTLE (72888-123-30)

Annotations

UNII (FDA Substance ID)
PML56A160O
GUANFACINE HYDROCHLORIDE
RxCUI 203142
Orange Book
A216762
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Guanfacine Hydrochloride Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "PML56A160O",
    "rxcui": "203142",
    "inchikey": "DGFYECXYGUIODH-UHFFFAOYSA-N",
    "display_name": "GUANFACINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6006df06-0448-462d-b81e-7add50a6d71b": {
      "match": "brand_token",
      "title": "GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "12",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72888-123_473ce2a5-25a3-811b-e063-6294a90a0456",
  "productndc": "72888-123",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216762",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Oct 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Oct 17, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GUANFACINE HYDROCHLORIDE",
  "shortage_reason": "Guanfacine Hydrochloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Guanfacine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216762",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guanfacine",
  "start_marketing_date": "20211001",
  "active_numerator_strength": "1"
}

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